Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 9:14 PM
Study NCT ID:
NCT03284294
Status:
UNKNOWN
Last Update Posted:
2020-04-02
First Post:
2017-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-31', 'studyFirstSubmitDate': '2017-09-04', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Function', 'timeFrame': 'At the end of week 8', 'description': 'cognitive function as measured with standard cognitive battery'}], 'secondaryOutcomes': [{'measure': 'BDNF serum level', 'timeFrame': 'At the end of week 8', 'description': 'BDNF serum level as measured with ELISA method'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic schizophrenia\n* Serum 25(OH)D level below 30 ng/ml\n* Deficit in cognitive functions\n\nExclusion Criteria:\n\n* Hypercalcemia\n* Hepatic or renal failure\n* Obese\n* Metabolic syndrome'}, 'identificationModule': {'nctId': 'NCT03284294', 'briefTitle': 'Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Padjadjaran'}, 'officialTitle': 'The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic', 'orgStudyIdInfo': {'id': 'PS-201709.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral placebo daily for 8 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks', 'interventionNames': ['Drug: Cholecalciferol']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'description': 'cholecalciferol 2000 IU oral daily for 8 weeks', 'armGroupLabels': ['Vitamin D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo daily for 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tuti Kurnianingsih, MD', 'role': 'CONTACT', 'email': 'kurniatuti@gmail.com', 'phone': '+62 812 232 9249'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Padjadjaran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tuti Kurnianingsih', 'investigatorAffiliation': 'Universitas Padjadjaran'}}}}